NEWS HIGHLIGHTS
Published Studies Related to Sublimaze (Fentanyl)
Assessment of the relative potency of fentanyl buccal tablet to intravenous
morphine in healthy volunteers using a thermally induced hyperalgesia pain model. [2012]
This exploratory randomized, double-blind, placebo-controlled, 5-treatment,
5-period crossover study was conducted using a thermally induced hyperalgesia
pain model in 51 healthy volunteers (33 evaluable) to characterize the relative
potency of fentanyl buccal tablet (FBT) versus intravenous morphine...
Evaluation of analgesic efficacy of intra-articular bupivacaine, bupivacaine plus fentanyl, and bupivacaine plus tramadol after arthroscopic knee surgery. [2011.12]
PURPOSE: To compare the efficacy of intra-articular (IA) bupivacaine, bupivacaine-fentanyl, and bupivacaine-tramadol for relief of postoperative pain after arthroscopic knee surgery... CONCLUSIONS: On the primary outcome measure (VAS pain score), both bupivacaine with fentanyl and bupivacaine with tramadol were better than IA bupivacaine, and bupivacaine with fentanyl was better than that with tramadol. However, both the combinations were comparable to each other with regard to the secondary outcome measure (supplementary analgesic requirement). Thus IA bupivacaine-fentanyl appears to be the best combination for relief of postoperative pain in patients undergoing arthroscopic knee surgery, followed by IA bupivacaine-tramadol. LEVEL OF EVIDENCE: Level I, randomized controlled trial. Copyright (c) 2011 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
A randomized control trial of patient-controlled epidural analgesia (PCEA) with and without a background infusion using levobupivacaine and fentanyl. [2011.12]
BACKGROUND: Continuous infusion associated with patient-controlled epidural analgesia (PCEA) is used in many maternal units. This randomized controlled study evaluated the effect of a 10 mL/h background infusion associated with a 10 mL-20 minutes lockout time demand-only PCEA protocol using L-bupivacaine plus fentanyl in terms of local anaesthetic consumption, pain management and maternal satisfaction... CONCLUSION: When a levobupivacaine plus fentanyl PCEA protocol with high volume boluses and long lockout interval is used for labour analgesia, the background infusion increased the total local anesthetic dose with no change in pain management and maternal satisfaction.
Effect of one minimum alveolar concentration sevoflurane with and without fentanyl on hemodynamic response to laryngoscopy and tracheal intubation. [2011.10]
BACKGROUND: Drug combinations can be used for optimum obtundation of the hemodynamic response to tracheal intubation. The objective of this trial was to compare the hemodynamic response to laryngoscopy and tracheal intubation after administration of 2 mug/kg fentanyl bolus or a placebo with 2% end tidal sevoflurane at induction of anesthesia... CONCLUSION: Addition of 2 mug fentanyl bolus to 1 MAC sevoflurane anesthesia at induction attenuated the hemodynamic response to a maximum of 15% above baseline values.
Effect of intravenous dezocine on fentanyl-induced cough during general anesthesia induction: a double-blinded, prospective, randomized, controlled trial. [2011.09.21]
PURPOSE: To evaluate the suppressive effect of intravenous dezocine on fentanyl-induced cough during the induction of general anesthesia... CONCLUSION: These results demonstrate that intravenous dezocine 0.1 mg/kg 10 min prior to induction was effective in suppressing fentanyl-induced cough in our patients.
Clinical Trials Related to Sublimaze (Fentanyl)
Conversion From Fast Acting Oral Opioids to Abstral� [Recruiting]
The purpose of this study is to evaluate safety and efficacy when using a novel dose
conversion strategy to switch from immediate release oral opioids to sublingual (SL)
fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor [Not yet recruiting]
Epidural analgesia is widely regarding as the most effective analgesic strategy for labor
pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along
with an opioid, e. g., our common "recipe" of 12 ml/hr of 0. 0625% bupivacaine with 2
micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery.
This dose of the infusion often provides adequate comfort without interfering with the
mobility of the patient and her ability to effectively push during delivery. However, this
low dose epidural infusion strategy often results in recurrence of pain after an initial
pain free period.
This breakthrough pain is treated by administering small boluses of analgesics via the
epidural catheter. The pain occurring in labor is initially of visceral origin and is
mediated by pain fibers originating from the low thoracic and upper lumbar segments of the
spinal cord. As labor progresses to the late first phase (also known as transitional stage),
pain sensations originating from the distension of the pelvic floor, vagina and perineum
adds a somatic component to labor pain. This type of breakthrough pain is often difficult to
treat.
Although requests from patients to alleviate late stage breakthrough pain are common, no one
knows the most effective strategy for pain management in this stage of labor. This study is
designed to compare the efficacy of two treatments for controlling late first stage
breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine
versus fentanyl-bupivacaine.
Women who have labor epidural analgesia in place will be enrolled to be randomized if and
when they present with breakthrough pain in the late first stage or second stage of labor
(≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75
micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist
known to be effective as an epidural analgesic).
Pain relief, labor progress and outcome will be assessed to compare fentanyl versus
clonidine.
It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic
than fentanyl added to bupivacaine for breakthrough pain in advanced labor.
Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients [Recruiting]
Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the
patient. The pain associated with the procedure is not caused by the insertion of the scope
but from inflating of the colon in order to do the inspection. It has been shown that
colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients
feel discomfort during the procedure. Factors predicting a painful colonoscopy are
female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy
(Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are
associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or
analgesia are achieved by administering a benzodiazepine or a combination of a
benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine
(Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol
as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of
colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most
commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely
increases the cost of procedure; drug administration, need for pulse oximetry monitoring and
the need for follow-up after the procedure make colonoscopy sometimes expensive and
troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor
makes patients forget it (Elphick et al. 2009).
Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal
sublingual formulation of fentanyl has been developed to further improve the management of
pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed
under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by
the body through the mucous membrane. After administration of buccal fentanyl maximum plasma
drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl
concentrations versus time following buccal and sublingual administration are very similar
(Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under
the tongue at the deepest part. Sublingual administration is an easy and non-invasive
method of pain treatment for the patient coming to colonoscopy done as an office based
procedure. Other advantages compared to invasive methods are improved comfort of patients
and no need for intravenous access because of pain relief. Before, it has been used in the
management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be
effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al.
2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients [Not yet recruiting]
Often, patients transported by aeromedical systems do not receive enough medication to
control and relieve their pain. The purpose of this study is to determine if pain treatment
with intravenous (IV) ketamine is a better way to treat aeromedical patients' pain than the
current treatment practices.
Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain [Not yet recruiting]
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